Status: Not yet recruiting

A Phase II Exploratory Study of SR604 Injection Evaluating the Safety and Efficacy in the Treatment of Congenital Coagulation Factor VII Deficiency

This is an open-label, multicenter, exploratory Phase II clinical trial designed to evaluate the efficacy, safety, and pharmacokinetic characteristics of SR604 Injection in patients with congenital coagulation Factor VII deficiency.

Participants needed: 12

Trial details

Phase: Phase 2Age: 18-65Biological sex: AllType: InterventionalSponsor: Shanghai RAAS Blood Products Co., Ltd.Updated: Jul 17, 2026Locations: 1

Eligibility criteria

Age ≥12 years and ≤65 years at the time of signing the informed consent form; bo... [+4]

Known history of hypersensitivity to the study drug formulation or any of its co... [+18]

Status: Recruiting

An Open-label, Multicenter Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetic/Pharmacodynamic (PK/PD) Characteristics of SR604 Injection in Patients With Hemophilia A/B and Congenital Factor VII Deficiency

The purpose of this study is to evaluate the safety, tolerability, immunogenicity , PK, and PD of a single dose of SR604 in participants with Hemophilia A or Hemophilia B, with or without inhibitors （Part A）and to evaluate the safety, PK, PD, and efficacy of multiple doses of SR604 in participants with Hemophilia A or Hemophilia B, or Factor VII (FVII) deficiency, with or without inhibitors (Part B and Part C).

Participants needed: 76

Trial details

Phase: Phase 1, Phase 2Age: 18-65Biological sex: AllType: InterventionalSponsor: Shanghai RAAS Blood Products Co., Ltd.Updated: Jun 12, 2026Locations: 9

Eligibility criteria

Age ≥18 years and ≤65 years at the time of signing informed consent, regardless... [+7]

Subjects with a known history of hypersensitivity to the investigational medicin... [+23]

Status: Recruiting

A Phase II Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of SR604 Injection in Patients With Von Willebrand Disease

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamic (PD) of SR604 in patients with von Willebrand disease.

Participants needed: 24

Trial details

Phase: Phase 2Age: 18-65Biological sex: AllType: InterventionalSponsor: Shanghai RAAS Blood Products Co., Ltd.Updated: Jun 11, 2026Locations: 9

Eligibility criteria

Age >= 18 years and <= 65 years at the time of signing informed consent, regardl... [+4]

Known history of hypersensitivity to the investigational drug formulation or any... [+23]

Clinical trials

A Phase II Exploratory Study of SR604 Injection Evaluating the Safety and Efficacy in the Treatment of Congenital Coagulation Factor VII Deficiency

An Open-label, Multicenter Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetic/Pharmacodynamic (PK/PD) Characteristics of SR604 Injection in Patients With Hemophilia A/B and Congenital Factor VII Deficiency

A Phase II Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of SR604 Injection in Patients With Von Willebrand Disease